TraumaOne SYSTEM 41-2010 (UDI 00888233000277)Recalls & reported problems

Summary

The FDA's MAUDE database contains 9 adverse event reports that list this exact device (DI 00888233000277), received between Dec 15, 2022 and Apr 29, 2026 — classified as 4 injuries, 5 malfunctions.

The most frequently reported specific device problem is “Fracture” (9 reports).

Reports come from manufacturers, hospitals and patients and are not verified by the FDA. A report does not prove the device caused the event, and counts can't be used to compare devices or estimate failure rates. How this data works · Data updated Oct 13, 2026.

Most reported problems

Recent adverse event reports

The 9 most recent of 9 reports, in the reporter's own words as published by the FDA.

• MalfunctionApr 29, 2026Fracture

  IT WAS REPORTED THAT DURING FIXATION OF A MESH TO A FOUR-HOLE PLATE USING 2.0 X 10 MM SCREWS, ONE SCREW FRACTURED. THERE WAS NO PATIENT INJURY AS A RESULT OF THE MALFUNCTION. ATTEMPTS HAVE BEEN MADE AND NO FURTHER INFORMATION HAS BEEN PROVIDED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 25035775 ↗
• MalfunctionDec 10, 2025Fracture; Fracture

  IT WAS REPORTED THAT DURING THE IMPLANTATION OF A STRAIGHT PLATE, TWO SCREWS FRACTURED. THERE WAS NO KNOWN IMPACT OR CONSEQUENCE TO THE PATIENT AT THE TIME OF THIS REPORT. ATTEMPTS HAVE BEEN MADE, AND NO FURTHER INFORMATION HAS BEEN PROVIDED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 23769569 ↗
• MalfunctionDec 10, 2025Fracture; Fracture

  NO FURTHER EVENT INFORMATION AVAILABLE AT THE TIME OF THIS REPORT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 23769544 ↗
• InjuryDec 10, 2025Fracture; Fracture

  IT WAS REPORTED THAT DURING THE IMPLANTATION OF A STRAIGHT PLATE, TWO SCREWS FRACTURED. ONE OF THE FRACTURED SCREWS WAS NOT ABLE TO BE REMOVED AND WAS RETAINED. THE SURGEON NOTED THAT THE FRACTURED SCREW WAS SERVING ITS INTENDED PURPOSE, SO IT WAS LEFT WITHIN THE PATIENT. IT IS UNKNOWN WHICH SCREW WAS RETAINED. ATTEMPTS HAVE BEEN MADE, AND NO FURTHER INFORMATION HAS BEEN PROVIDED.

  Patient problems: Foreign Body In Patient; No Clinical Signs, Symptoms or Conditions

  MAUDE report 23769542 ↗
• InjuryDec 10, 2025Fracture; Fracture

  IT WAS REPORTED THAT DURING THE IMPLANTATION OF A STRAIGHT PLATE, TWO SCREWS FRACTURED. ONE OF THE FRACTURED SCREWS WAS NOT ABLE TO BE REMOVED AND WAS RETAINED. THE SURGEON NOTED THAT THE FRACTURED SCREW WAS SERVING ITS INTENDED PURPOSE, SO IT WAS LEFT WITHIN THE PATIENT. IT IS UNKNOWN WHICH SCREW WAS RETAINED. ATTEMPTS HAVE BEEN MADE, AND NO FURTHER INFORMATION HAS BEEN PROVIDED.

  Patient problems: Foreign Body In Patient; No Clinical Signs, Symptoms or Conditions

  MAUDE report 23769510 ↗
• MalfunctionOct 16, 2024Fracture; Fracture

  IT WAS REPORTED THAT DURING AN INITIAL PROCEDURE FOR FIXATION OF THE PLATE IN THE MANDIBLE, THE SCREW FRACTURED. THE PROPER SURGICAL TECHNIQUE WAS USED. THE FRACTURED SCREW PARTS WERE REMOVED FROM THE PATIENT, AND THE PROCEDURES WERE COMPLETED SUCCESSFULLY USING AN ALTERNATIVE DEVICE. ATTEMPTS HAVE BEEN MADE, AND NO FURTHER INFORMATION HAS BEEN PROVIDED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 20461708 ↗
• MalfunctionOct 16, 2024Fracture; Fracture

  IT WAS REPORTED THAT DURING AN INITIAL PROCEDURE INVOLVING THE PLACEMENT OF THE BONE FLAP, THE SCREW FRACTURED. THE PROPER SURGICAL TECHNIQUE WAS USED. THE FRACTURED SCREW PARTS WERE REMOVED FROM THE PATIENT, AND THE PROCEDURES WERE COMPLETED SUCCESSFULLY USING AN ALTERNATIVE DEVICE. ATTEMPTS HAVE BEEN MADE, AND NO FURTHER INFORMATION HAS BEEN PROVIDED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 20461703 ↗
• InjuryMar 21, 2023Fracture; Fracture

  IT WAS REPORTED THAT DURING THE PLACEMENT OF THE PLATE, A SCREW FRACTURED LEAVING A FRAGMENT IMBEDDED IN THE PATIENT. A DIFFERENT SCREW FROM THE SYSTEM WAS USED TO COMPLETE THE PROCEDURE.

  Patient problems: Foreign Body In Patient

  MAUDE report 16584024 ↗
• InjuryDec 15, 2022Fracture; Fracture

  IT IS REPORTED THAT DURING THE PLACEMENT OF A SCREW FOR FIXATION OF A TRAUMA ONE PLATE, THE ANKLE HEAD FRACTURED LEAVING THE BODY INSIDE THE PATIENT'S BONE AND GENERATING REARRANGEMENT OF THE PLATE FOR FIXATION IN ANOTHER AREA.

  Patient problems: Foreign Body In Patient

  MAUDE report 15988471 ↗